MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2012-004035-23-HU
• Date of registration: 01/08/2013
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
• Public title: MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin
• Scientific title: A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin) in Pediatric Subjects with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy - MK-0431A XR in Pediatric Patients with T2DM and Inadequate Glycemic Control on Metformin
• Date of first enrolment: 23/09/2013
• Target sample size: 240
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004035-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Greece, Hungary, India, Israel, Italy, Russian Federation, South Africa

Contacts

• Name: Ravi Shankar
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

• Name: Ravi Shankar
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has type 2 diabetes mellitus
2. Subject has an A1C =6.5% and =10.0% on a stable dose of metformin IR or XR (=1500 mg/day) for =12 weeks before Visit 1
3. Subject is between 10 and 17 years of age (inclusive) on day of signing informed consent with randomization to occur prior to the subject’s 18th birthday
4. Subject has not received treatment with insulin for at least 6 months prior to the Screening Visit/Visit 1
5. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one “yes” response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication: (a) Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement "c" if heterosexual activity is initiated or (b) Patient agrees to abstain from heterosexual activity or (c) Patient agrees to use an adequate method of contraception.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subject has known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies, or known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
2. Subject has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, saxagliptin, or linagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide)
3. Subject has symptomatic hyperglycemia and/or moderate ketonuria requiring immediate initiation of another antihyperglycemic agent.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 Diabetes Mellitus
MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: MK0431A XR
Product Code: MK0431A XR
Pharmaceutical Form: Tablet
INN or Proposed INN: sitagliptin phosphate
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Metformin
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: MK0431A XR
Product Code: MK0431A XR
Pharmaceutical Form: Tablet
INN or Proposed INN: sitagliptin phosphate
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Metformin
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Glucophage SR
Product Name: Metformin Hydrochloride Prolonged Release
Product Code: Metformin Hydrochloride Prolonged Release
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Other descriptive name: N, N-dimethylimidodicarbonimidic diamide hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Glucophage SR
Product Name: Metformin Hydrochloride Prolonged Release
Product Code: Metformin Hydrochloride Prolonged Release
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Other descriptive name: N, N-dimethylimidodicarbonimidic diamide hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Over 54 weeks, to assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A XR) in pediatric patients (ages 10-17 years)
with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

after 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to the addition of placebo on
A1C in pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

Over 54 weeks, to assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) in pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

Secondary Objective: After 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to placebo on fasting plasma
glucose (FPG) in pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

After 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to placebo on the proportion
of patients initiating glycemic rescue therapy in pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

Timepoint(s) of evaluation of this end point: 20 Weeks

Primary end point(s): A1C

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 20 Weeks

Secondary end point(s): Fasting plasma glucose, proportion of subjects initiating glycemic rescue, proportion of subjects with A1C at goal

Secondary ID(s)

0431A-0289

2012-004035-23-CZ

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as